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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027658
Receipt No. R000031684
Scientific Title Effects of a group alcohol intervention for evacuees after the Great East Japan Earthquake
Date of disclosure of the study information 2017/06/06
Last modified on 2017/08/07

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Basic information
Public title Effects of a group alcohol intervention
for evacuees after the Great East Japan
Earthquake
Acronym Alcohol Intervention
Scientific Title Effects of a group alcohol intervention
for evacuees after the Great East Japan
Earthquake
Scientific Title:Acronym Alcohol Intervention
Region
Japan

Condition
Condition The evacuees who might have risk of
alcohol abuse
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to identify the risk factor of alcohol use disorders among evacuees
after the Great East Japan Earthquake,
and develop a group alcohol intervention
program.
Basic objectives2 Others
Basic objectives -Others This presents two studies. The first
study aims to develop a questionnaire to
identify change in alcohol consumption
factors among the evacuees after the Great East Japan Earthquake. In the second study, we developed a group alcohol intervention program based on the Hizen Alcoholism Program by Yuzuriha (HAPPY) to investigate how the intervention could be effective for the evacuees who might have risk of
alcohol abuse
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a. Participants' sociodemographic information and disaster-related situations
b. Burn-out Inventory
c. PHQ-9
d. AUDIT
e. Participants' drinking behavior
f. SOCRATES
g. Alcohol class evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Alchol consumption between pre-post
alcohol class
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Only those that informed consent was
obtained
Key exclusion criteria None
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maeda, Masaharu
Organization Fukushima Medical University
Division name Department of Disaster Psychiatry
Zip code
Address Hikarigaoka 1 Fukushima-city, Fukushima
TEL 024-547-1887
Email masagen@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ueda, Yuka
Organization Fukushima Medical University
Division name Department of Epidemiology
Zip code
Address Hikarigaoka 1 Fukushima-city, Fukushima
TEL 024-547-1343
Homepage URL
Email yukaueda@hotmail.com

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 30 Day
Last follow-up date
2016 Year 12 Month 21 Day
Date of closure to data entry
2017 Year 01 Month 10 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 06 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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